FDA Warns Consumers of Contaminated Copycat Eye Drops: Urges Caution and Vigilance

In a public announcement on January 31, 2024, the U.S. Food and Drug Administration (FDA) issued a stern warning to consumers, cautioning against the purchase and use of certain eye drop products due to potential contamination and health risks. The implicated products—South Moon, Rebright, and FivFivGo—are identified as copycat eye drops that closely resemble Bausch + Lomb’s Lumify brand eye drops, an over-the-counter product approved for redness relief

The FDA emphasized that South Moon, Rebright, and FivFivGo eye drops are unapproved drugs, rendering them unauthorized for sale in the United States. Disturbingly, these copycat products claim to address serious eye conditions such as glaucoma, a medical issue typically treated with prescription drugs or surgery.

Consumers are urged to refrain from using or purchasing these unapproved eye drops immediately. Additionally, patients exhibiting signs or symptoms of an eye infection after using these products are advised to consult with their healthcare provider promptly or seek medical attention. The FDA underscores the importance of properly discarding any of these contaminated products.

The FDA conducted thorough testing on samples of South Moon and Rebright eye drops, both of which were purchased online. Results revealed that South Moon eye drops were contaminated with Burkholderia cepacia complex, a group of bacteria notorious for causing antibiotic-resistant infections. While Rebright testing yielded negative results for contamination, the FDA still advises against its use. Notably, both South Moon and Rebright were found to lack brimonidine tartrate, the active ingredient present in the FDA-approved Lumify eye drops. Unfortunately, the origin of FivFivGo remains uncertain as the FDA was unable to obtain samples for testing.

Concerningly, the FDA has not received any adverse event reports specifically linked to South Moon, Rebright, or FivFivGo products. However, the agency has received reports related to potentially fake Lumify products, including concerns regarding product quality, eye irritation, pain, and infection.

As part of their ongoing investigation, the FDA is working to determine the origin of these copycat products. South Moon is purportedly labeled as manufactured by Shantou Cross-border Premium Products E-Commerce Co. Ltd. in China. Consumers are strongly advised to exercise caution when purchasing eye products, opting to buy only from reputable retailers, such as state-licensed pharmacies. Furthermore, the FDA warns against relying on online retailers that make false claims about their products.

To assist consumers in distinguishing between authentic Lumify eye drops and the counterfeit products, the FDA provided a visual comparison. The South Moon, Rebright, and FivFivGo copycat eye drops displayed images that may falsely bear the label “Bausch + Lomb” at the top of the packaging. The FDA emphasized that the actual appearance of these copycat products may differ from authentic Lumify eye drops.

In an effort to enhance consumer safety, the FDA encourages healthcare professionals and consumers alike to report any adverse events or side effects associated with the use of these copycat eye drops. Reports can be submitted online through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program or by downloading and completing a form, which can then be submitted via fax at 1-800-FDA-0178.

In conclusion, this FDA warning serves as a vital reminder for consumers to exercise caution when purchasing over-the-counter medications, particularly those available online. The risks associated with unapproved and contaminated products emphasize the importance of obtaining medications from reputable sources and promptly reporting any adverse effects to regulatory authorities for further investigation and action.

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